NCT04879797

Reducing Racial Disparities in Severe Maternal Morbidity

Status unknown NA Last updated 13 September 2023

What this trial tests

NA trial testing Implementation of Maternal Safety Bundles in Maternal Death in 1,538 participants. Status unknown.

Timeline

1 October 2021

Primary endpoint
30 June 2024

30 June 2025

Quick facts

Lead sponsor	Tufts University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	1,538
Start date	1 October 2021
Primary completion	30 June 2024
Estimated completion	30 June 2025
Sites	1 location across United States

Drugs / interventions tested

• Implementation of Maternal Safety Bundles
• Doula Services

Conditions studied

• Maternal Death — all drugs for Maternal Death →

Sponsor

Tufts University

Who can join

Eligibility, female only, with Maternal Death. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is a paucity of research examining the intersection of race, ethnicity, maternal safety bundles, doulas, and maternal outcomes in Black women at increased risk of severe maternal morbidity and mortality. The proposed mixed-methods study is the first systematic investigation of pregnancy complications and outcomes among Black women with whom maternal safety bundles are being implemented including racial disparities, hemorrhage, and hypertension. Additionally, through the analysis of secondary state level data, this study will examine perinatal care, maternal outcomes, and healthcare utilization of Black women at increased risk of severe maternal morbidity and mortality compared with non-Latino white women. Finally, through individual interviews with Black women and focus groups with obstetric health providers and doulas, the study will examine disparities and improve care by creating and disseminating a set of practice recommendations for maternity care for Black women at increased risk of morbidity and mortality.

Research has not yet examined the intersection of race/ethnicity, doulas, and quality improvement (QI) interventions, such as maternal safety bundles, on reducing SMM and mortality among non-Hispanic Black (NHB) women. The overall goal of this mixed-methods study is to use analysis of existing big data and the evaluation of two interventions to ultimately develop targeted recommendations for addressing these inequities. Our approach leverages multiple data sources to study maternal outcomes and access to care during the prenatal, birth, and postpartum periods in order to identify commonalities among women who experienced SMM and use those findings to create a risk profile of women who are more likely to experience SMM; examine the implementation of maternal safety bundles on SMM and MM outcomes for women up to 1 year postpartum (Intervention 1); gather in-depth data from obstetric care providers on factors that support or hinder safety bundle implementation (Intervention 1); and gather in-depth data from individual women and doulas on facilitators of barriers to the use of doulas to improve care and address inequities (Intervention 2).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.